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NCT05913973 · ClinicalTrials.gov registry record · Phase 1
Study of the Plasmodium Vivax Transmission-blocking Vaccine Pvs230D1-EPA/Matrix-M to Assess Safety, Immunogenicity, and Transmission-blocking Activity in Healthy Malaria-naive Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
NCT05913973: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05913973 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05913973, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
Study Summary
Background: Malaria is a disease carried by mosquitoes in tropical countries around the world. It can cause symptoms like fever, body aches, and weakness. More than half a million people worldwide died of malaria in 2021, mostly children. Researchers want to find ways to prevent the spread of this disease. Objective: To test the effects of a new malaria vaccine. (Volunteers will not be exposed to malaria.) Eligibility: Healthy adults aged 18 to 50 years. Design: Volunteers will be screened. They will have a physical exam with blood and urine tests. They will take a short quiz to make sure they understand the study. Volunteers will have 3 visits to receive the vaccine. These visits will be about 1 month apart. The vaccine will be injected into the muscle of the upper arm. Volunteers will have 12 additional clinic visits. These will start after the first vaccine visit and continue for 8 months. The visits may include a physical exam and blood tests. There will also be 7 follow-up phone calls. These will occur the day after each vaccine visit and then continue for another 12 months. Participants will be asked how they are doing and whether they have had any changes in their health. ...
Primary Outcome
Incidence and severity of local and systemic adverse events (AEs) or serious adverse events (SAEs)
Interventions
- DRUG Pvs230D1-EPA/Matrix-M
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2023-08-04 |
| Est. Completion | 2025-11-12 |
| Phase | Phase 1 |
What the finished NCT05913973 record still lists
NCT05913973 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 1 intervention - of which Pvs230D1-EPA/Matrix-M is the first listed.
NCT05913973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05913973 about?
NCT05913973 is a clinical study titled "Study of the Plasmodium Vivax Transmission-blocking Vaccine Pvs230D1-EPA/Matrix-M to Assess Safety, Immunogenicity, and Transmission-blocking Activity in Healthy Malaria-naive Adults". Background: Malaria is a disease carried by mosquitoes in tropical countries around the world. It can cause symptoms like fever, body aches, and weakness. More than half a million people worldwide died of malaria in 2021, mostly children. Researchers want to find ways to prevent the spread of this ...
What is the current status of trial NCT05913973?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2023-08-04. Estimated completion is 2025-11-12.
What interventions are being tested in trial NCT05913973?
The interventions under investigation include: Pvs230D1-EPA/Matrix-M (DRUG).
Who is sponsoring clinical trial NCT05913973?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05913973's enrollment target sits among peer trials
105 533rd of 2000 higher than 1,465 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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